Kirschner Self-Tapping Acetabular Cup

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K852351 ↗

FDA Product Code

KWA

Device Class

Class III

Regulation

21 CFR Part 888.3330

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Dosimetric Release of Gamma Radiation

  Class II

  FDA 510(k) K832211 Active Cleared 29 Sep 1983

• Austin Moore Hip Prosthesis

  Not classified

  FDA 510(k) K863896 Active Cleared 19 Nov 1986

• Dimension Total Hip Prosthesis

  Class II

  FDA 510(k) K853333 Active Cleared 3 Sep 1985

• Compression System

  Class II

  FDA 510(k) K831076 Active Cleared 28 Apr 1983

• Wire & Steinman Pins

  Class II

  FDA 510(k) K831005 Active Cleared 18 May 1983

• Kirschner(R) Modular II-C(Tm) Total Shoulder System

  Class II

  FDA 510(k) K940537 Active Cleared 29 Aug 1995

See all devices from Kirschner Medical Corp. →

• What types of hip surgeries is the Kirschner Self-Tapping Acetabular Cup intended for, and how does its self-tapping feature benefit the procedure?

  The Kirschner Self-Tapping Acetabular Cup is designed specifically for total hip arthroplasty, where it serves as a metal acetabular component to replace the damaged hip joint. The self-tapping mechanism simplifies placement by allowing the cup to cut into the bone during insertion, which helps achieve a more stable and secure uncemented fixation within the pelvic acetabulum without requiring additional tools or steps.

• How many sizes are available for the Kirschner Self-Tapping Acetabular Cup, and how are they identified?

  The cup is available in multiple sizes, each identified by a unique FEI (Final Establishment Identifier) number. There are over 50 distinct FEI numbers listed, ensuring compatibility with a wide range of patient anatomies and surgical requirements. These sizes are critical for achieving proper fit and alignment during total hip arthroplasty.

• Is the Kirschner Self-Tapping Acetabular Cup meant for single-use or can it be reused after sterilization?

  The device is explicitly labeled as a single-use component and must be handled in accordance with sterile surgical protocols. Reuse is not recommended or supported by the manufacturer, as it could compromise sterility and patient safety.

• What regulatory pathway was followed for FDA clearance of the Kirschner Self-Tapping Acetabular Cup, and when was it granted?

  The Kirschner Self-Tapping Acetabular Cup received FDA clearance under the Traditional 510(k) pathway, with a decision of Substantially Equivalent (SESE) in 1985. The clearance number is K852351, and it was granted on August 9, 1985, following review by the Orthopedic (OR) Advisory Committee.

• How should the Kirschner Self-Tapping Acetabular Cup be stored to maintain its sterility and functionality?

  Since the cup is sterile and single-use, it should be stored in its original packaging in a clean, dry environment away from direct sunlight or extreme temperatures. The packaging must remain intact until immediately before use to preserve sterility and ensure the device remains ready for surgical application.